MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
|ClinicalTrials.gov Identifier: NCT03193736|
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : April 7, 2020
The study will evaluate the efficacy and safety of the implant and IOP lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.
The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.
|Condition or disease||Intervention/treatment||Phase|
|Open Angle Glaucoma||Device: MINIject implant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Open, Multicenter Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications|
|Actual Study Start Date :||June 19, 2017|
|Actual Primary Completion Date :||April 16, 2018|
|Actual Study Completion Date :||November 25, 2019|
Device: MINIject implant
MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention.
The intervention is to be performed as stand-alone surgery.
- reduction in medicated diurnal IOP [ Time Frame: 6 months after surgery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193736
|Maxivision Eye Hospital|
|Hyderabad, Telangana, India, 500034|
|Clinica de ojos Orillac-Calvo|
|Panama city, Panama|
|Study Director:||Zubair Hussain||iSTAR Medical|